This position functions primarily in a controlled-non-classified (CNC) environment and requires the individual to wear appropriate PPE. This position will perform labeling, visual inspection, and other duties, such as cleaning, restocking, and waste destruction, as required and/or assigned. All assigned tasks must be conducted in adherence with all applicable procedures, cGMPs, company policies and any other quality or regulatory (Ex: OSHA, DEA, FDA, etc.) requirements. Facility is a multiple shift operation where variable shifts, including weekends, may be required. Hours of Work: 8-hour shift Monday through Friday |
SAFETY Strictly adhere to all cGMP, health and safety requirements, procedures, and corporate policies.Authorized to immediately stop any task that is determined to be an imminent hazard.Always promote and demonstrate safe work practices and adhere to PPE requirements.Safely handle chemicals, corrosives, solvents, and other pharmaceutical compounds.Demonstrate physical ability to lift a minimum of 50 lbs. and push/pull pallets, product cans, etc. multiple times per shift. PRIMARY RESPONSIBILITIES: All responsibilities of Production Associate I AND the following:Learn to operate all relevant automation technology and equipment for labeling and visual inspection operations.Obtain and maintain visual inspection qualification for NLT 2 additional unique processes including, but not limited to:On-Q pumpsIV BagsProvide effective leadership, advice, instructions, and training to others regarding operations for labeling, visual inspection, and support processes.Demonstrate basic troubleshooting skills and the ability to make recommendations or collaborate on solutions for resolving issues.Make minor adjustment to equipment to address issues.Complete documentation reviews as required or assigned. |
Arrive for work on-time, prepared to work in the CNC environment for the majority of each shift.Operate with Integrity by maintaining high ethical standards. Treat all employees with trust, respect, and professionalism. Speak up and hold others accountable for high integrity by providing constructive feedback. Take accountability for individual and team mistakes and participate in related corrective actions.Ensure patient safety by understanding you and your team’s impact on product quality.Excel within a diverse and high performing team. Remain open to new ideas and perspectives, communicate across shifts as required, and comply with site process to create a safe work environment. Demonstrate a passion to perform by meeting personal and departmental goals. Self-driven and self-accountable, performs required tasks, and progresses on qualifications within reasonable timelines.Demonstrate innovation abilities by identifying and speaking up about viable options for improvements and exploring and creating a path for implementation. |
High School Diploma or equivalent.Must pass a drug test.Must speak, write, and read English.Must be a team player.Must have excellent attention to detail. |
Prior cGMP experience.Knowledge of FDA guidelines, cGMP, and GDP.Willingness to participate in training and gain other certifications as needed.Knowledge of basic arithmetic and chemistry calculations.Ability to work in a fast-paced environment with dynamic priorities and demands.Excellent written and verbal communication skills.Desire to expand knowledge and grow with the company.Leadership ability. |
Production Lead
The Production Lead’s responsibilities include: Supporting all aspects of Production for sterile drug products, overseeing Production Technicians and performing technician duties such as batch kitting, formulation, aseptic filling, inspection and labeling. Overseeing implementation and compliance with STAQ Quality Systems (includes SOPs, WIs, etc.), continuous quality improvement activities, etc. Ensuring compliance current Good Manufacturing Practices (cGMP), and applicable regulatory (e.g., FDA, DEA, BoP, OSHA) requirements and guidance. |
Assist employees who are responsible for product formulation, aseptic filling, inspection and labeling, or facility cleaning and disinfection. Demonstrate mastery and provide formal training and education to employees in areas of good documentation practices, gowning, formulation, aseptic filling, and other applicable production processes.Demonstrates and serves as an example to others safe work culture including PPE use, chemical and material handling. Perform equipment calibrations according to SOPs and troubleshoot equipment as needed.Coordinate with leadership on Production schedule and ensure daily tasks and resources are allocated to support schedule and achieve Production goals. Provide leadership with a focus on creating and maintaining a positive work environment through effective communication and positive training experiences. Mentor team members and support career advancement within the organization. Participate in the creation, review, and revision of procedures, policies, and other quality documents that pertain to Production. Identify and analyze production efficiencies, downtime, and waste. Lead and encourage teams to improve results and production output. Exercise discretion, judgment, and personal responsibilityAssist with writing non-conformances that occur in the department. Assist Quality to quickly resolve any variance or document errors so that product may be released on time. Supports technical teams such as engineering, R&D, facilities, etc. in their activities and goals.Demonstrate ability to lift/push/pull a minimum of 50 pounds.Demonstrates ability to stand and walk for extended periods of time. |
High School Diploma or GED required.Minimum 5 years of general work experience.Minimum 3 years of experience in a cGMP FDA regulated manufacturing environment; 2 or more years aseptic processing preferred. Computer literate in Microsoft Office (PowerPoint, Excel, Word)Knowledge of cGMP requirements and guidance.Ability to perform basic pharmaceutical calculations. |
Experience with gowning and aseptic processing in a manufacturing setting.Demonstrated effective and respectful interaction skills and a measurable track record of influence at all levels of an organization. Organizational, motivational, and analytical problem solving skills. Excellent written and verbal communication skills.Ability to work in a fast-paced environment with dynamic priorities and demands. |
Filling Technician
This position functions primarily in a classified ISO-7 environment and requires the individual to wear appropriate PPE. This position will support sterile filling operations and perform other duties, such as cleaning, restocking, visual inspection, and labeling, as required and/or assigned. All assigned tasks must be conducted in adherence with all applicable procedures, cGMPs, company policies and any other quality or regulatory (Ex: OSHA, DEA, FDA, etc.) requirements. Facility is a multiple shift operation where variable shifts, including weekends, may be required. Hours of Work: 8-hour shift Monday through Friday. 0600-1430 or 1400-2230. |
SAFETY Strictly adhere to all cGMP, health and safety requirements, procedures, and corporate policies.Authorized to immediately stop any task that is determined to be an imminent hazard.Always promote and demonstrate safe work practices and adhere to PPE requirements.Safely handle chemicals, corrosives, solvents, and other pharmaceutical compounds.Demonstrate physical ability to lift a minimum of 50 lbs. and push/pull pallets, product cans, etc. multiple times per shift. PRIMARY RESPONSIBILITIES: Perform ISO-7 support functions for aseptic filling operations consistent with established protocols, procedures, and regulatory/cGMP requirements.Learn to utilize all relevant equipment/technology for filling operations.Responsible for acquiring and maintaining classified area gowning qualification.Complete and document required training to gain proficiency for all assigned job tasks.Accurately and contemporaneously document all actions performed per GDP standards.Assist with classified and non-classified area cleaning and maintenance as required.Perform visual inspection, labeling, and additional support tasks as required.Make recommendations for process improvements.Possess the ability to master multiple processes across different areas.Recognize and respond appropriately to equipment/documentation issues and deviations; obtain appropriate clarification and guidance from leadership before proceeding.Maintain a quality focused, “Right First Time”, attitude. |
Arrive for work on-time, prepared to work in the classified environment for the majority of each shift.Operate with Integrity by maintaining high ethical standards. Treat all employees with trust, respect, and professionalism. Speak up and hold others accountable for high integrity by providing constructive feedback. Take accountability for individual and team mistakes and participate in related corrective actions.Ensure patient safety by understanding you and your team’s impact on product quality.Excel within a diverse and high performing team. Remain open to new ideas and perspectives, communicate across shifts as required, and comply with site process to create a safe work environment. Demonstrate a passion to perform by meeting personal and departmental goals. Self-driven and self-accountable, performs required tasks, and progresses on qualifications within reasonable timelines.Demonstrate innovation abilities by identifying and speaking up about viable options for improvements and exploring and creating a path for implementation. |
High School Diploma or equivalent.Must pass a drug test.Must speak, write, and read English.Must be a team player.Must have excellent attention to detail. |
Prior Sterile Compounding and Pharmaceutical Industry experience.Prior experience operating manufacturing equipment/machinery.Knowledge of FDA guidelines, cGMP, and GDP.Willingness to participate in training and gain other certifications as needed.Knowledge of basic arithmetic and chemistry calculations.Ability to work in a fast-paced environment with dynamic priorities and demands.Excellent written and verbal communication skills.Desire to expand knowledge and grow with the company.Leadership ability. |
Production Supervisor
STAQ Pharma is currently hiring for a production supervisor to join our team here in the Columbus area
JOB DESCRIPTION | |
Summary | The Production Supervisor provides leadership and supervision support for multiple production areas such as formulation, aseptic filling, inspection, and labeling/packaging. This position manages day-to-day cGMP manufacturing activities and collaborates with other departments to achieve production goals. Is trained and qualified in controlled and aseptic gowning and provides on-the-floor support to production personnel in (CNC) and Classified (ISO 8, ISO 7, ISO 5) environments as needed. This position is responsible for implementation and compliance with STAQ Quality Systems (includes SOPs, WIs, etc.), continuous quality improvement activities, and ensuring compliance cGMP and applicable regulatory (e.g., FDA, DEA, OSHA) requirements. |
Safety and Responsibilities | SAFETY Strictly adheres to all regulatory requirements, health and safety (e.g., OSHA, EPA, RCRA) requirements, procedures, work instructions, and corporate policies.Immediately stops any task that is determined to be an imminent hazard.Promotes and demonstrates safe work practices and adhere to PPE requirements.Safely handles chemicals, corrosives, solvents, and other pharmaceutical compounds.Demonstrates physical ability to lift a minimum of 50 lbs. and push/pull pallets, product containers, etc., multiple times per shift. PRIMARY RESPONSIBILITIES Supervise employees who are responsible for formulation; aseptic filling; inspection and labeling; or facility sanitization. Position may have dotted line supervision to other areas of operations.Provide support to technicians who are responsible for product formulation, aseptic filling, inspection and labeling, or facility cleaning and disinfection. Participate in production activities as required. Coordinate training and education for employees in areas of good documentation practices, gowning, formulation, aseptic filling, and other applicable production processes. Ensure employees trainings are completed on time. Assist in interviewing, hiring, and onboarding operations personnel. Demonstrates and serves as an example to others safe work culture including PPE use, chemical and material handling. Create and maintain production schedule with input from key leadership, and ensure daily tasks and resources are allocated to support schedule and achieve Production goals. Participate in the creation, review, and revision of batch records, procedures, policies, and other quality documents that pertain to Operations. Identify and analyze production efficiencies, downtime, and waste. Leads team to improve results and production output. Exercise discretion, judgment, and personal responsibilityRecognizes and initiates deviations when discovered. Appropriately investigates and documents in a timely manner. Implements corrective actions and CAPAs as required. Supports technical teams such as engineering, R&D, facilities, etc. in their activities and goals.Ensure all SOPs are current, training on SOPs and processes remains current and compliance with STAQ Quality Systems.Analyze Production efficiencies, downtime, and waste. Lead teams to improve results and production output. Write or assist with writing non-conformances that occur in the department. Work with Quality to quickly resolve any variance or document errors so that product may be released on time. Supports technical teams such as engineering, facilities, etc. in their activities.Assist in managing staffing levels and budget spending when necessary. |
Values and Behaviors | Demonstrates accountability by ensuring the production team operates according to procedures and completes all tasks as required. Recognizes individual and team deviations and leads the related investigations and corrective actions.Provide strong people leadership with a focus on creating/maintaining a positive work environment through effective communication, performance management, accountability, etc. This includes time and attendance review and maintenance for all department employees.Demonstrates integrity by maintaining high ethical standards and treats all employees with trust, respect, and professionalism. Respectfully holds others accountable by providing constructive feedback. Leads a diverse and high performing team. Remains open to new ideas and perspectives, communicate across shifts as required, and complies with procedures to create a safe work environment. Demonstrates motivation by implementing and progressing towards departmental and company goals. Demonstrates courage and innovation by speaking up about viable options for improvements and supporting successful implementation. |
Required Qualifications and Education | 4-year accredited college degree, or 5+ years of experience in a cGMP production environment, preferably pharmaceutical manufacturing.3 or more years of leadership/supervisory experience; 2 or more years aseptic processing preferred. |
Preferred Skills | Experience with project management and change control. Demonstrated effective and respectful interaction skills and a measurable track record of influence and leadership at an organization. Demonstrated organizational, motivational, analytical problem-solving and strategic thinking skills. Excellent written and verbal communication skills.Ability to lead a team in a fast-paced environment with dynamic priorities and demands. |
Supply Chain Manager
STAQ Pharma, Inc., a leader in the 503B pharmaceutical manufacturing industry, is seeking an experienced and dynamic Manager of Supply Chain to oversee and manage supply chain operations across two key sites: Columbus, OH, and Denver, CO. This role will be physically located at our Columbus, OH facility. The ideal candidate will possess a deep understanding of supply chain management, particularly within the pharmaceutical manufacturing sector, and will be adept at driving efficiency, cost savings, and operational excellence across multi-site operations.
Key Responsibilities:
- ERP System Implementation:
- Integrate/convert our current inventory management system into our new ERP system (Microsoft Dynamics 365).
- Implement barcode scanning/RFID technology for all raw material inventory to enhance accuracy and efficiency.
- Inventory Management:
- Utilize the large warehouse capabilities in Columbus to purchase and manage inventory volumes that serve both the Columbus and Denver sites effectively.
- Coordinate regular truck shipments from Columbus to Denver to support production operations while adhering to Denver’s warehouse constraints.
- Monitor and manage long lead-time inventory to ensure timely availability of materials for both sites.
- While the Supply Chain team is built out, the Manager of Supply Chain is expected to be heavily involved in the day-to-day operations. Such as, ordering, safety stock calculations, sourcing, etc.
- Supply Chain Processes and SOPs:
- Own, develop, and continuously improve all supply chain-related Standard Operating Procedures (SOPs) and processes to ensure compliance and operational efficiency.
- Implement best practices and innovative solutions to enhance supply chain operations.
- Vendor Relations and Contract Negotiations:
- Establish and maintain strong relationships with vendors to ensure reliable supply and favorable terms.
- Negotiate contracts, rebate programs, and purchase agreements that yield cost savings and mitigate risks.
- Identify and manage single points of failure in the supply chain to ensure business continuity.
- Team Building and Leadership:
- Responsible for building out the supply chain team over the next year to support the growing needs of the company.
- Provide leadership, mentorship, and direction to the developing supply chain team to ensure high performance and professional growth.
- Cost Management and Savings:
- Develop and execute strategies to optimize procurement and inventory management costs.
- Analyze and implement opportunities for cost savings without compromising quality or compliance.
Qualifications:
- Bachelor’s degree in Supply Chain Management, Business Administration, or a related field. Advanced degree preferred.
- Minimum of 5 years of experience in supply chain management, with at least 2 years in a leadership role preferably within the pharmaceutical or healthcare manufacturing industry.
- Proven experience in ERP system implementation and inventory management.
- Strong knowledge of pharmaceutical manufacturing regulations and requirements.
- Excellent negotiation, communication, and relationship management skills.
- Ability to manage multi-site operations and balance competing priorities effectively.
- Strong analytical and problem-solving skills.
- Proficiency in Microsoft Office Suite and supply chain management software.
- Ability to travel up to 25%
- Proactively formulates activities, sets direction, and prioritizes tasks with minimal management oversight. Strong people management skills.
- Ensure compliance with all relevant laws, regulations, and standards regarding supply chain operations.
- Collaborate with internal departments, such as Production/Operations, Sales, and Finance, to understand their supply chain needs and ensure timely delivery of materials and products.
- Demonstrated willingness to help others and take on duties to make STAQ successful.
Why STAQ Pharma, Inc.:
- Opportunity to lead and innovate within a growing company in the pharmaceutical manufacturing sector.
- Collaborative and dynamic work environment.
- Competitive salary and comprehensive benefits package.
- Opportunity to make a significant impact on the company’s operations and success.
Production Technician
This entry-level Operations position functions as part of the Production Team and independently performs material handling, cleaning, visual inspection, labeling, and packaging. As personnel develop skills and demonstrate mastery of assigned tasks, Production Technicians may progress to perform additional activities including formulation and classified area cleaning. This position is trained in controlled and classified area gowning and performs majority of job function in Controlled Non-Classified (CNC) and Classified (ISO 8, ISO 7) environments.
Performs all job functions in adherence with cGMP, company policies, and any other quality or regulatory (e.g., OSHA, DEA, FDA, etc.) requirements.
Duties/Responsibilities:
SAFETY
- Strictly adheres to all regulatory requirements, health and safety (e.g., OSHA, EPA, RCRA) requirements, procedures, work instructions, and corporate policies.
- Immediately stops any task that is determined to be an imminent hazard.
- Promotes and demonstrates safe work practices and adhere to PPE requirements.
- Safely handles chemicals, corrosives, solvents, and other pharmaceutical compounds.
- Demonstrates physical ability to lift a minimum of 50 lbs. and push/pull pallets, product containers, etc., multiple times per shift.
PRIMARY RESPONSIBILITIES:
- Performs cleaning activities in the production areas.
- Performs documentation, set-up, cleaning, and maintenance of rooms and equipment.
- Executes all processes as defined in the batch record, procedures, and work instructions consistent with regulatory/cGMP requirements.
- Performs material handling and material transfer withing warehouse, CNC, and classified areas.
- Performs Visual Inspection of finished products.
- Performs Labeling and Packaging of finished products.
- Performs Formulation of intermediate bulk drug according to batch record.
- Maintains training and qualification in all areas as required.
- Demonstrates basic troubleshooting skills.
- Uses equipment according to procedures and work instructions.
- Completes cGMP documentation reviews as required or assigned.
- Performs other duties as assigned.
- Demonstrates ability to recognize and respond to potential deviations from the defined process.
Required Skills/Abilities:
- Demonstrates ability and motivation to progress to a Production Technician II and/or master multiple processes within assigned work area.
- Demonstrates accountability by arriving at work at scheduled start time, prepared to work in the CNC or classified environment for most of each shift. Recognizes individual and team deviations and accepts responsibility for making corrections and improvements.
- Demonstrates integrity by maintaining high ethical standards and treats all employees with trust, respect, and professionalism.
- Speaks up and holds others accountable by providing constructive feedback.
- Ensures patient safety by understanding individual and team impact on product quality.
- Participates effectively on a diverse and high performing team. Remains open to new ideas and perspectives, communicate across shifts as required, and complies with procedures to create a safe work environment.
- Demonstrates motivation by meeting personal and departmental goals. Self-driven and self-accountable, performs required tasks, and progresses on qualifications within reasonable timelines.
- Demonstrates courage and innovation by speaking up about viable options for improvements and supporting a path for implementation.
Education and Experience:
- High School Diploma or equivalent.
- Must pass drug screening and vision screening.
- Must speak, write, and read English.
- Must be a team player.
- 1+ years of continuous work experience
- Prior experience in a regulated manufacturing industry.
- Knowledge of basic arithmetic and chemistry calculations.
- Ability to work in a fast-paced environment with dynamic priorities and demands